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Intercept Pharmaceuticals, Inc.

http://www.interceptpharma.com

Latest From Intercept Pharmaceuticals, Inc.

Intercept Plans To Refile OCA For NASH At US FDA With Consensus Reads Of Patient Biopsies

Additional patients and more long-term data could also help make case for obeticholic acid. Intercept hopes to complete its review of the pivotal REGENERATE trial during H1 2022.

Drug Review Drug Approval Standards

NASH Updates: Intercept Moves Toward Re-Filing, Madrigal De-Risks Phase III

AASLD Briefing: While working on new biopsy reviews to address CRL, Intercept also might consider filing for approval in cirrhotic patients if REVERSE study succeeds. Plus other updates on NASH programs.

Clinical Trials Drug Approval Standards

Metacrine’s Shift Means Further Attrition In FXR Agonist Class For NASH

Metacrine halts development of its FXR agonist compounds in NASH and turn its focus to inflammatory bowel disease. Firm plans Phase II ulcerative colitis study in 2022 with MET642.

Business Strategies Drug Approval Standards

Metacrine Choosing Between Two NASH FXR Agonists It Calls Best-In-Class

Biotech is determining which of its mid-stage FXR candidates – MET409 and MET642 – will offer the best overall profile to take into Phase IIb. It is also studying ‘409 in combination with Jardiance and will test the FXR class in inflammatory bowel disease.

Clinical Trials Research & Development
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